Regulatory Affairs Jobs at Medline
Medline is hiring a Regulatory Affairs Specialist to support global regulatory activities for medical devices. This is a full-time, remote role. The Regulatory Affairs Jobs at Medline focus on developing regulatory strategies, preparing and maintaining submissions, and ensuring ongoing compliance across global markets. The position plays a key role in supporting new product launches, post-market changes, and regulatory lifecycle management.
About the Company:
Medline Industries is a global leader in medical supplies and healthcare solutions, supporting healthcare providers worldwide. With a strong focus on innovation, regulatory excellence, and inclusion, Medline offers employees opportunities for professional growth within a fast-growing, global organization.
Job Details:
- Job ID: R2601211
- Job Title: Regulatory Affairs Specialist
- Employment Type: Full-time
- Work Mode: Remote
- Location: Northfield, Illinois (Remote Eligible)
- Travel Requirement: Up to 5%
Educational Requirements for the Regulatory Affairs Specialist Role:
- Bachelor’s degree (B.A. or B.S.) in Life Sciences, Regulatory Science, or a related field
Work Experience Required:
Minimum 2 years of experience in:
- Medical Device Regulatory Affairs or
- Quality Assurance within a regulated environment
Key Responsibilities of the Regulatory Affairs Specialist:
- Plan and execute global regulatory activities to obtain and maintain product approvals
- Determine regulatory requirements for product submissions and market clearances
- Develop regulatory strategies for new devices, new markets, and post-market changes
- Communicate regulatory requirements and pathways to internal and external stakeholders in the Regulatory Affairs Jobs at Medline
- Review technical documentation and supporting evidence for regulatory compliance
- Prepare, submit, and maintain regulatory filings across assigned markets
- Collaborate cross-functionally to respond to regulator questions and non-conformances
- In the Regulatory Affairs Jobs at Medline, you should support the development, review, and substantiation of product labeling and claims
- Act as a regulatory subject matter expert within project teams
- Present regulatory objectives, resolve issues, and support short-term department goals
Skills & Competencies Required for the Regulatory Affairs Jobs:
- Strong understanding of the current global regulatory environment
- Applied knowledge of FDA regulations and guidelines
- Ability to assess compliance with applicable standards, laws, and regulations
- Strong documentation, analytical, and problem-solving skills
- Effective communication and stakeholder management abilities
- Ability to work independently while collaborating across teams
Salary & Compensation for the Regulatory Affairs Jobs:
- Annual Salary Range: $79,000 – $119,000 USD
- Salary varies based on Location, Education, Experience, Skills, and abilities
- Bonus and/or incentive eligible
- Medline complies with all applicable minimum wage and salary thresholds
Benefits & Perks
- Comprehensive health insurance (medical, life, disability)
- 401(k) contributions
- Paid time off
- Continuing education and training opportunities
- Employee Assistance Program (EAP)
- Employee Resource Groups and inclusion initiatives
- Career growth opportunities within a global organization
